Human Factors Regulatory Consultant

Sagentia Innovation provides independent advisory and leading-edge product development services focused on science and technology initiatives. We work across the medical, industrial, chemicals and energy, food and beverage, and consumer sectors, and with a broad range of companies from some of the world’s leading and best-known brands, to start-up disruptors new to the market. Our breadth of expertise brings together the best people to solve a problem and can include our scientists, engineers, human factors experts, data and AI scientists, innovation strategists, product developers and designers, and consumer insight specialists.

The opportunity
To support Sagentia Innovation’s increasing Human factors compliance offering within our Medical Sector, we are recruiting a Human Factors Regulatory Consultant to join our world class team of product developers and R&D strategists. Working with our Head of Human Factors (HF), this role will give you the opportunity to support and develop HF/Usability Engineering Files and use-related risk documentation, ensuring best practice and consulting directly with our clients on key HF projects.
Success in the role will require collaboration with multidisciplinary medical device development teams in Sagentia Innovation, as well as collaboration with our client’s project teams

We have:
• A multitude of exciting medical, diagnostic and combination device projects for you to engage in the HF activities, implementation and project documentation.
• Experienced applied science, engineering, and embedded software teams to help collaborate with from insight generation to summative study and regulatory submission.
• An extensive advisory team delivering strategic visions and roadmaps requiring a human centered approach.

You will have:
• Proven experience working in a HF function guiding pragmatic activities and documenting outputs in accordance with FDA human factors guidelines, MDR, IEC:62366 and HE 75 regulatory requirements. These include:
• Creation of use specifications, user interface specifications and user interface evaluation plans, workflow assessment and task analysis
• Hazard and risk related documentation and traceability including uFMEA/UERAs
• Experience of Medical device project quality management in a project-based organisation.
• Knowledge of ISO 13485, FDA QSR and Medical Device Directive (MDD)/Medical Device Regulations (MDR) to support additional quality engineering functions.
• A Degree level qualification in a relevant engineering, design or science discipline.

You might also have (but not essential):
• Experience in the recruitment, leading and documentation of Voice of Customer, Formative and Summative engineering studies.
• Previous background in a product design function.
• Knowledge of generating technical publications, such as accompanying documentation and training materials
• Worked in a client facing consulting environment.

Career development
We offer bespoke training and mentoring to allow you to thrive within our environment and fully realize your personal goals and potential. You will have the opportunity to develop:
• QMS continuous improvements and be involved in internal projects relating to the implementation of new tools that may enhance our HF function
• Business development expertise by providing pre-sales input and assistance, interfacing directly with clients under the guidance of our business development team.
• Strong interpersonal and communication skills, to gain the confidence and capability required in a client facing role.

Benefits
You will be offered a competitive salary and benefits package.

 

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